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Nasopharyngeal CancerPhase 2NCT04925544

Novel Small Molecule EBNA1 Inhibitor, VK 2019, in Patients With Epstein Barr Virus (EBV)-Positive Nasopharyngeal Cancer (NPC) and Other Epstein-Barr Virus (EBV)-Associated Cancers, With Pharmacokinetic and Pharmacodynamic Correlative Studies

A Phase 2 study testing VK-2019 in people with Nasopharyngeal Cancer and Epstein-Barr Virus Related Carcinoma, run by Stanford University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

To evaluate the anti cancer effect of VK 2019 in subjects with EBV related nasopharyngeal carcinoma (NPC) for whom there is no other standard treatment available Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
VK-2019
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteUnited States
Study dates
25 Jan 2022to 17 Jun 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1 Informed consent obtained prior to any protocol mandated study specific procedures in accordance with institutional policies.
  • 2 Either loco regionally recurrent or metastatic EBV positive RECIST evaluable nasopharyngeal carcinoma not amenable to curative treatment with no accepted effective standard of care therapeutic option.
  • Addendum for phase 2 exploratory cohorts: subjects with PTLD or EBV lymphoma not amenable to curative treatment with no accepted effective standard of care therapeutic option.
  • 3 Not eligible for other approved or standard therapies
  • 4.Prior palliative radiation must have been completed at least 2 weeks prior to study Cycle 1 Day 0
  • 5.Prior anti cancer systemic treatment must have been completed greater than 4 weeks prior to the first dose of VK 2019 or subjects must have recovered from all acute prior treatment related AEs
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  • 6.Toxicities related to prior anti cancer therapy must have returned to Grade 1 or less. Peripheral neuropathy must be Grade 2 or less. Chronic but stable toxicities Grade > 1 (eg, dysphasia, G tube dependence, etc.) are permissible.
  • 7.Age ≥ 18
  • 8.Absolute neutrophil count > 1500/µL (stable off any growth factor for at least 1 week of study drug administration)
  • 9.Hemoglobin > 9g/dL (transfusion to achieve this level is permitted)
  • 10.Platelet count > 75 x 103/ µL (transfusion to achieve this level is NOT permitted)
  • 11.Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 2.5 x upper limit of normal (ULN) .Total serum bilirubin ≤ 1.5 x ULN
  • 12.Serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min as calculated per Cockcroft Gault equation
  • 13.Urinary protein < 2+ by dipstick. If dipstick ≥ 2+, then a 24 hour urine collection can be done and the subject may enter only if urinary protein is < 1 g/24 hour
  • 14.Sexually active subjects must agree to utilize birth control method during treatment and for 18 weeks after the last dose of VK 2019.
  • 15.Eastern Cooperative Oncology Group (ECOG) performance status 2 or less.
  • 16.Ability to understand and the willingness to personally sign the written IRB approved informed consent document.

Who cannot join

  • 1.Prior therapy restrictions.
  • 2.Concurrent treatment with systemic cancer directed therapy including complementary, alternative, herbal or nutritional supplement based treatments whose purpose is for anti cancer effect
  • 3.Severe or active symptomatic cardiopulmonary diseases, including unstable angina, congestive heart failure, or peripheral vascular disease within 12 months prior to study drug administration; and/or chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization within 4 weeks prior to study drug administration. Subjects with effectively treated conditions (eg, stenting for coronary artery disease) are eligible if stable for at least 4 weeks prior to study drug administration
  • 4.Metastatic disease with active central nervous system (CNS) involvement, defined as parenchymal brain involvement. Subjects with cranial nerve or base of skull involvement without the above are eligible. Subjects with CNS metastases that are stable on imaging at least 1 month following focal treatment with radiation are eligible
  • 5.Known history of human immunodeficiency virus (HIV) unless the HIV positive subjects has:
  • A stable regimen of highly active anti retroviral therapy (HAART)
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  • No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections
  • A CD4 count above 250 cells/mcL and an undetectable HIV viral load on standard PCR based test
  • 6.Serious uncontrolled medical disorder or active infection which would, in the opinion of the Investigator, impair the ability of the subject to receive protocol therapy or whose control may be jeopardized by the complications of this therapy
  • 7.NPC subjects: Have received a prior organ allograft or allogeneic bone marrow transplant.
  • 8.Current non prescription drug or alcohol dependence
  • 9.For all female subjects: pregnancy or breastfeeding
  • 10.All female subjects with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment
  • 11.Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, or in the judgment of the investigator would make the subject inappropriate for entry into the study
  • 12.Corrected QT by Fridericia's formula (QTcF) of > 470 ms average (mean) on triplicate ECG performed during screening

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford University

    Stanford, California, 94305

Other trials in United States

About this study

Official title: Phase 2, Open-label, Clinical Trial of a Novel Small Molecule EBNA1 Inhibitor, VK 2019, in Patients With Epstein Barr Virus Positive Nasopharyngeal Cancer (NPC) and Other EBV-associated Cancers, With Pharmacokinetic and Pharmacodynamic Correlative Studies

To evaluate the anti cancer effect of VK 2019 in subjects with EBV related nasopharyngeal carcinoma (NPC) for whom there is no other standard treatment available

Read the detailed description

Primary Objective: To characterize the anti tumor effect of VK 2019 in subjects with EBV related cancer.

Secondary Objective: 1. To characterize the safety profile, survival, PK and PD in the studied subject populations 2. To explore clinical activity and safety on subjects with post transplant lymphoproliferative disorder (PTLD) and EBV related lymphoma.

Being tested
VK-2019
Keywords
Epstein-Barr Virus, Nasopharyngeal Carcinoma, Nasopharynx cancer, VK-2019, NPC, EBNA1 inhibitor, EBV
Medical subject headings
Nasopharyngeal Neoplasms, Epstein-Barr Virus Infections, Nasopharyngeal Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VK-2019Drug

    VK-2019 binds to EBNA1 and inhibits EBNA1 DNA binding activity. VK-2019 API is synthesized by Anthem BioSciences Pvt. Ltd and formulated into capsules by Emerson Resources Inc,

Study groups in NCT04925544
Study groupRoleWhat they receive
VK-2019_armExperimentalDose escalation and expansion up to 31 additional patients at a maximum of 1800 mg twice daily. Cycles will be defined as 28 days of treatment, subjects will receive VK 2019 until progression or dose limiting toxicity, for up to 12 cycles.
Receives: Drug: VK-2019

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate

    Response rate to VK 2019 in EBV related NPC subjects will be assessed using RECIST v 1.1 criteria. Response Evaluable Subjects: All treated subjects with measurable disease at baseline and one of the following: 1) at least one post dose tumor assessment, 2) discontinuation prior to the first efficacy assessment due to clinical disease progression or toxicity or 3) death either on treatment or within 28 days of last VK 2019 dose.

    Measured: 12 months

Secondary outcomes (7)

  1. Progression free survival

    Progression free survival (PFS) per RECIST v 1.1 from time of subject registration. Reported as the number of subjects remaining alive at the assessment timepoint, without progression.

    Measured: 24 months

  2. Overall survival

    Overall survival from time of subject registration. Reported as the number of subjects remaining alive at the assessment timepoint.

    Measured: 24 months

  3. Area under the plasma concentration versus time curve (AUC)

    Area under the plasma concentration (AUC) for VK 2019 and metabolites will be estimated using non compartmental analysis. Analysis population is defined as all enrolled subjects treated who have at least one of the PK parameters of interest. The median AUC values by cohort, with standard deviation, obtained after 2 cycles will be reported.

    Measured: Day 56 (ie, Day 0 Cycle 3 after 2, (each cycle is 28 days)

  4. Time to maximum plasma concentration (Tmax),

    Time to maximum plasma concentration (Tmax) for VK 2019 and metabolites will be collected, Analysis population is defined as all enrolled subjects treated who have at least one of the PK parameters of interest. The median value of Tmax by cohort, with standard deviation, obtained after 2 cycles will be reported.

    Measured: Day 56 (ie, Day 0 Cycle 3 after 2, (each cycle is 28 days)

  5. Peak Plasma Concentration (Cmax)

    Maximum plasma concentration (Cmax) will be collected. Analysis population is defined as all enrolled subjects treated who have at least one of the PK parameters of interest. The median value of Cmax by cohort, with standard deviation, obtained after 2 cycles will be reported.

    Measured: Day 56 (ie, Day 0 Cycle 3 after 2, (each cycle is 28 days)

  6. Safety profile

    Measure the number of adverse events (AEs), Serious adverse events (SAEs), and Dose Limiting Toxicities (DLTs) by cohort, for up to 12 months.

    Measured: 12 months

  7. Pharmacodynamic EBV DNA

    Median difference from treatment to Day 56 (ie, Day 0 Cycle 3 after 2 28-day cycles) for the levels of cell free plasma EBV DNA by cohort, with standard deviation will be measured

    Measured: Day 56 (ie, Day 0 Cycle 3 after,2 (each cycle is 28-day)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2021
  2. Study start25 Jan 2022
  3. Primary completion17 Jun 2026 (estimated)
  4. Study completion17 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Two stage phase 2 single arm trial with three strata: 1. EBV related NPC subjects receiving VK 2019 2. EBV related lymphoma subjects receiving VK 2019 3. EBV related PTLD subjects receiving VK 2019
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04925544
Sponsor's protocol ID
IRB-59886
Other IDs
VAR0207, 5R01CA235633, NCI-2022-02830
Status last verified
Oct 2025
First submitted
18 May 2021
Last updated
24 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VK-2019 in people with Nasopharyngeal Cancer and Epstein-Barr Virus Related Carcinoma, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04925544.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.

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